Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2015-07-23
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate the clinical response and safety of CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhangjiang Biotechnology Limited Company
• Collaborators: Shanghai Biomabs Pharmaceutical Co., Ltd.; Shanghai Biomabs Pharmaceuticals Co Ltd
• Treatments: Camptothecin; Cetuximab; Irinotecan

Criteria

Inclusion Criteria:

• histologically confirmed metastatic colorectal adenocarcinoma

• KRAS wild-type tumors, EGFR-expressing or EGFR-nonexpressing by immunohistochemistry;

• has measurable lesion, at least 1cm in diametre by CT or MRI, at least 2cm diametre by physical examination or other iconography

• ECOG performance status 0 to 1

• Failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve

Exclusion Criteria:

• Previous irinotecan or anti-EGFR therapies

• hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic millimeter

• liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the upper limit of normal with hepatic metastasis or not

• Renal function: serum creatinine, more than 1.5 times the upper limit of normal

• Patients with symptomatic central nervous system metastases